China NMPA Product Recall - Disposable bone cement molds for temporary femoral prosthesis molding; bone cement molding molds for knee joints.

Zimmer Biomet (Shanghai) Medical International Trading Co., Ltd. initiated a voluntary Class II recall of specific disposable bone cement molds, as reported by the National Medical Products Administration (NMPA) on March 3, 2020. This action, also highlighted by the Shanghai Municipal Drug Administration, impacts all batches of disposable bone cement molds for temporary femoral prosthesis molding (Registration Certificate No.: 20163461466) and bone cement molding molds for knee joints (Registration Certificate No.: 20162101535). The recall stems from issues discovered during a complaint investigation, revealing a potential deficiency in the cleaning process or insufficient monitoring of cleaning parameters for these medical devices. The company is actively addressing the concern by removing the affected products from the market to ensure patient safety and compliance with medical device regulations under the NMPA framework.